Endpoint summary

Administrative data

Description of key information

The informtion for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 406.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation, other

Remarks:

OECD 406

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb 13 - Mar 09, 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

There is adequate information from a OECD 406 study available and no OECD 429 study is thus needed to be performed.

Qualifier:

according to

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Principles of method if other than guideline:

None

GLP compliance:

yes (incl. certificate)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

There is adequate information from a OECD 406 study available and no OECD 429 study is thus needed to be performed.

Species:

guinea pig

Strain:

other: HsdPoc:DH

Sex:

female

Details on test animals and environmental conditions:

** Test SystemGuinea pig, HsdPoc:DH, femalesBreeder: Harlan Winkelman GmbH, Borchen Age: about 3 - 5 weeksThe mean initial body weight at the start of the study was 325 g (range from 271 to 376 g).The body weight of two animals at the start of the study was outside the range as described in the study plan (300 to 450 g). This minor deviation did not influence the outcome of the study.In a large number of tests, with a variety of test materials, the guinea pig and the specific strain used has proven to be a species well suited for skin sensitization studies.Identification and adaptionHealthy young animals were allocated to the study groups at least 7 days before dosing to allow them to acclimatize. The guinea pigs were identified by colour mark, whereas the pretest animals were marked with a different colour than the animals of group 1 and 2 (details are documented in the raw data).Assignment20 guinea pigs were used in this study.Pretest: 5 femalesGroup 1: negative control group (5 females) Group 2: test material group (10 females)- Housing:Five guinea pigs were housed in type GMI5 (EBECO) Makrolon cages with a shelter and placed on mobile racks. The animals were kept on conventional softwood granulate as the bedding. The bedding was changed two times a week.- Diet (e.g. ad libitum): Diet and community tap water from Makrolon drinking bottles were available to the guinea pigs ad libitum.The diet, Provimi Kliba 3418.0, was checked according to the specifications of the manufacturer by independent laboratories. Analysis included both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides and antibiotics. The tap water was analyzed periodically according to the German regulations for human drinking water. The softwood granulate was analytically checked by independent laboratories.ENVIRONMENTAL CONDITIONSTemperature and atmospheric humidity were measured by a thermohygrograph. The room temperature within the study period was 22 to 23 °C and the relative atmospheric humidity 55 to 62%.

Positive control results:

50% positive reactions with control substance

Reading:

1st reading

Hours after challenge:

48

Group:

test group

Dose level:

25 g/L (induction I), 7.5 g/L (induction II), 2.5 g/L (challenge)

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no signs of toxicity

Remarks on result:

no indication of skin sensitisation

Reading:

2nd reading

Hours after challenge:

72

Group:

test group

Dose level:

25 g/L (induction I), 7.5 g/L (induction II), 2.5 g/L (challenge)

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no signs of toxicity

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

not sensitising

Remarks:

Migrated informationCriteria used for interpretation of results: other: CLP

Conclusions:

Under the given experimental conditions, the test material induced no reactions. According to EU Regulation No. 1272/2008 (CLP), the test material is not classified as a skin sensitizer.

Executive summary:

Purpose

The purpose of this GPMT assay was to identify the contact allergenic potential of teh test material. This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man.

Study Design

The test material was investigated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969).

5 females were treated with the vehicles liquid paraffin and polyethylene glycol 400 (group 1) and 10 females were treated with the test material (group 2).

Induction included intradermal injection of test material preparation in liquid paraffin (25 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of test material preparation in polyethylene glycol 400 (7,5 g/L) for 48 hours on experimental day 8.

Challenge by topical application of the test material preparation in polyethylene glycol 400 (2,5 g/L) for 24 hours was performed two weeks after topical induction and readings were taken at 48 hours and 72 hours after start of treatment.

Results

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. After challange no positive reactions were seen 48 or 72 hours after treatment with the test material.

Conclusion

Under the given experimental conditions, the test material induced no reactions. According to EU Regulation No. 1272/2008 (CLP), the test material is not classified as a skin sensitizer.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated from Short description of key information: Under the given experimental conditions, the test material induced no reactions. According to EU Regulation No. 1272/2008 (CLP), the test material is not classified as a skin sensitizer.

Justification for selection of skin sensitisation endpoint: This study was performed according to GLP and the methods applied are fully compliant with OECD TG 406.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.